Beginning Monday, May 21, 2012, we will be offering 1:1 (FDA SPL Team & SPL document author) 15-minute SPL Technical Q&A sessions. These SPL Tech Q&A teleconference 15-minute sessions will afford an opportunity for a company representative to attend an SPL Tech Q&A session to ask SPL technical questions at a scheduled time agreed upon by the FDA SPL team and a company representative. The Monday SPL Tech Q&A group sessions will still be held and questions may still be e-mailed to spl@fda.hhs.gov.
Registration for these sessions begins on Monday, May 21, 2012. Registration requests for these sessions received prior to Monday, May 21, 2012, will receive a response which includes a note about the May 21, 2012, start date.
To request a session, please follow these instructions:
Send an e-mail to spl@fda.hhs.gov with the following information:
Subject line of e-mail: Request for 1:1 SPL Tech Q&A 15-Minute Session - [Company Name] Body of e-mail:
1. Name of company 2. Name of contact person 3. Time Zone 4. Country 5. List of SPL technical questions
Following these instructions will ensure that the SPL team can efficiently respond to and schedule SPL Tech Q&A 1:1 teleconferences as soon as possible.
Reminder: Registration for these sessions begins on Monday, May 21, 2012.
FDA SPL Tech Q&A Sessions
Information for the SPL technical Q&As audio conference. Day of the Week: Mondays (except federal holidays or when the federal government in the Washington DC metropolitan area is closed due to inclement weather or other reasons) Time: 11:00 a.m. - 11:30 a.m., ET. Location: Audio conference Audio Conference Details: Telephone number: 1-866-775-9435/Participant pass code: 5753366
The time was altered from 10:00 a.m., ET (7:00 a.m. PT) to permit drug companies located in the Pacific time zone to attend the call beginning at 8:00 a.m., PT.
Training
Resources
SPL Roadmap (a guide to getting started with SPL R4):SPL eBooks available here.
SPL eCards available here.
new! 10-Jan 2013
2013 FDA Training Sessions Schedule
FDA SPL Tech Q&A Sessions - 1-on-1 between company rep and SPL team
Beginning Monday, May 21, 2012, we will be offering 1:1 (FDA SPL Team & SPL document author) 15-minute SPL Technical Q&A sessions. These SPL Tech Q&A teleconference 15-minute sessions will afford an opportunity for a company representative to attend an SPL Tech Q&A session to ask SPL technical questions at a scheduled time agreed upon by the FDA SPL team and a company representative. The Monday SPL Tech Q&A group sessions will still be held and questions may still be e-mailed to spl@fda.hhs.gov.
Registration for these sessions begins on Monday, May 21, 2012. Registration requests for these sessions received prior to Monday, May 21, 2012, will receive a response which includes a note about the May 21, 2012, start date.
To request a session, please follow these instructions:
Send an e-mail to spl@fda.hhs.gov with the following information:
Subject line of e-mail: Request for 1:1 SPL Tech Q&A 15-Minute Session - [Company Name]
Body of e-mail:
1. Name of company
2. Name of contact person
3. Time Zone
4. Country
5. List of SPL technical questions
Following these instructions will ensure that the SPL team can efficiently respond to and schedule SPL Tech Q&A 1:1 teleconferences as soon as possible.
Reminder: Registration for these sessions begins on Monday, May 21, 2012.
FDA SPL Tech Q&A Sessions
Information for the SPL technical Q&As audio conference.Day of the Week: Mondays (except federal holidays or when the federal government in the Washington DC metropolitan area is closed due to inclement weather or other reasons)
Time: 11:00 a.m. - 11:30 a.m., ET.
Location: Audio conference
Audio Conference Details: Telephone number: 1-866-775-9435/Participant pass code: 5753366
The time was altered from 10:00 a.m., ET (7:00 a.m. PT) to permit drug companies located in the Pacific time zone to attend the call beginning at 8:00 a.m., PT.
Presentations from Previous Years' Training
20122011
2010
20092008:SPL Xforms Traing Video Series
SPL Xforms Training Videos - Group A - Basic Instructions for Using the SPL Xforms
Part One - Intro to the SPL Xforms & Buttons/Tabs
Part Two - Types of Xforms Fields & Selecting a Template
Part Three - Document Tracking Information
Part Four - Saving SPL Files
Part Five - Validating an SPL File Using SPL Xforms
Part Six - Updating an SPL File
Module
Two Series of webinars on specific aspects of SPL R4 creation and transmission - not specific to particular areas of industry
Animal Drug - Electronic Drug Establishment Registration and Drug Listing in SPL R4 format training session - February 17, 2009
Individual sponsor FDA sessions
-GPhA Webinars and/or On-site Training
-DIA Webinars and/or On-site Training
-Other Webinars and/or AudioConferences and/or On-Site Training